To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.

Eligibility

Ages Eligible for Study:

13 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir.

Didanosine (ddI) may be continued or initiated in any patient during the study.

Topical acyclovir.

Topical ophthalmics.

Aerosolized pentamidine.

Patients must have:

AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV.

Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea.

Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex.

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000688